盐酸洛美沙星分散片体外溶出度测定方法的建立

目的:建立盐酸洛美沙星分散片体外溶出度的测定方法。方法:分别以水、磷酸盐缓冲液(pH6.8)、醋酸盐缓冲液(pH4.0)和盐酸溶液(0.1mol.L-1)为介质,篮法、转速100r.min-1条件下测定盐酸洛美沙星分散片在不同时间点的累积溶出率,采用紫外分光光度法在287nm波长下测定含量,确定溶出度的测定方法。结果:以盐酸溶液(0.1mol.L-1)为介质时,样品溶出更快、更平稳;确定溶出度检查取样时间为15min,限度标准为80%。结论:建立的盐酸洛美沙星分散片的体外溶出度测定方法可行。

Establishment of the Method for the Dissolution Determination of Lomefloxacin Hydrochloride Dispersible Tablet in Vitro

OBJECTIVE:To establish the method for the dissolution determination of Lomefloxacin hydrochloride dispersible tablet in vitro.METHODS:Accumulative dissolution rates of Lomefloxacin hydrochloride dispersible tablet at different time points were determined by basket method at rotation speed of 100 r·min-1 using water,phosphate buffer solution(pH 6.8),acetate buffer solution(pH 4.0) and hydrochloric acid solution(0.1 mol·L-1) as medium.The content of drugs was determined by UV spectrophotometry at 287 nm to determine the dissolution determination.RESULTS:Sample was dissolved more fastly and stable in hydrochloric acid solution(0.1 mol·L-1).The sampling time of dissolution determination was 15 min and the limit was 80%.CONCLUSION:The method that established for the dissolution determination of Lomefloxacin hydrochloride dispersible tablet was feasible.